KENGREAL® (cangrelor) in high-risk PCI

Patients at higher risk for periprocedural thrombotic events benefited from KENGREAL1

In a post hoc analysis of CHAMPION PHOENIX, patients with more complex lesions had higher periprocedural thrombotic event rates, and the absolute benefit of KENGREAL increased progressively with the number of high-risk lesions treated.1

≥3 angiographichigh-risk lesion features~25% of patients had

These 9 prespecified angiographic high-risk lesion features were included in the analysis:

  • long lesions (>20 mm)
  • thrombotic lesions
  • eccentric lesions
  • left main lesions
  • tortuous lesions
  • calcified lesions
  • bifurcation lesions
  • angulated lesions
  • multi-lesion PCI

Blinded angiographic core laboratory analysis was completed in 10,854 of the 10,942 (99.2%) randomized modified intention-to-treat patients in CHAMPION PHOENIX (13,418 target lesions).

PCI patients with high-risk characteristics can differ in disease severity and comorbidities, and not all high-risk lesion characteristics were accounted for in the present analysis. Treatment protocols should account for individualization of care as KENGREAL may not be appropriate for some patients.

  • 48-hour outcomes were analyzed according to the number of prespecified angiographic high-risk lesion features treated in all patients

Patients with more complex lesions had higher thrombotic event rates1

48-hour event rates by number of angiographic high-risk features treated1

95% confidence intervals appear under each rate estimate in parentheses.

*MACE is the measure of death, MI, ischemia-driven revascularization, or ST.

†Comparison between 0 and ≥3 high-risk features.

The absolute benefit of KENGREAL in PCI increased progressively with the number of high-risk lesion features treated1

48-hour MACE by number of angiographic high-risk lesion features treated1

Number of high-risk features per patientMACE at 48 hr (%)108642001233.34.46.98.71.83.86.06.4OR (95% CI) =0.54 (0.29, 0.99)OR (95% CI) =0.87 (0.62, 1.22)OR (95% CI) =0.86 (0.64, 1.16)OR (95% CI) =0.72 (0.54, 0.96)KENGREAL®(n=5426)Clopidogrel (n=5428)Number per group172517151411149013901304Clopidogrel:KENGREAL:898918Pinteraction=0.46

48-hour stent thrombosis by number of angiographic high-risk lesion features treated1

Number per group898918172517151411149013901304Clopidogrel:KENGREAL:3210OR (95% CI) =0.34 (0.04, 3.27)OR (95% CI) =0.78 (0.40, 1.55)OR (95% CI) =0.80 (0.42, 1.54)OR (95% CI) =0.43 (0.23, 0.82)0.30.11.11.42.31.01.10.9Number of high-risk features per patientST at 48 hr (%)Pinteraction=0.460123KENGREAL®(n=5426)Clopidogrel (n=5428)

This is a post hoc analysis and presents findings that supplement the predefined primary results of the CHAMPION PHOENIX trial. The CHAMPION PHOENIX trial was not designed nor powered to examine the impact of KENGREAL and clopidogrel on specific angiographic risk characteristics, lesion types, and outcomes.

Important Safety Information

KENGREAL® (cangrelor) for Injection is contraindicated in patients with significant active bleeding.

KENGREAL® is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product.

Drugs that inhibit platelet P2Y12 function, including KENGREAL®, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL® than with clopidogrel. Bleeding complications with KENGREAL® were consistent across a variety of clinically important subgroups. Once KENGREAL® is discontinued, there is no antiplatelet effect after an hour.

The most common adverse reaction is bleeding.

Indication

KENGREAL® (cangrelor) for Injection is a P2Y12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

References: 1. Stone GW, Généreux P, Harrington RA, et al. Impact of lesion complexity on peri-procedural adverse events and the benefit of potent intravenous platelet adenosine diphosphate receptor inhibition after percutaneous coronary intervention: core laboratory analysis from 10,854 patients from the CHAMPION PHOENIX trial. Eur Heart J. 2018;39(46):4112-4121. 2. KENGREAL® (cangrelor) Prescribing Information. 2016.